Mobile Health Intervention for Young Adult Cancer Survivors

(mHealthAYA Trial)

Overseen By Hannah Arem, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Significant psychological disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

155 Participants Needed

Trial Summary

What is the purpose of this trial?

We aim to refine and pilot test an 8-week phone- and app-based intervention to promote hope, and thereby mitigate life disruption caused by cancer diagnosis and treatment, among young adults (YAs); our proposal involves (Aim 1) formative research among YA survivors and healthcare providers; and (Aim 2) an randomized controlled trial (RCT) of the intervention vs. attention control among 150 YA cancer survivors. The proposed research is innovative in its use of: 1) a novel intervention target - hope - as a mechanism for addressing goal-disruption and quality of life (QOL) among YA survivors; and 2) novel mHealth components and population-based recruitment strategy (via social media) that are particularly relevant to YA survivors and those with potentially limited access to healthcare. This proposal has potential high impact due to the number of YA cancer survivors for whom the intervention may be relevant, the intervention's potential utility in enhancing hope and QOL among YAs, and its reach/scalability.

Research Team

Carla J Berg, PhD

Principal Investigator

George Washington University

Eligibility Criteria

This trial is for young adults aged 20-39 who have been treated for stages I-IV cancer within the last three years. Participants should not have significant psychological disabilities, must understand English, and need to have a smartphone. They also must be willing to commit to an 8-week study that's delivered remotely.

Inclusion Criteria

I was diagnosed with cancer between the ages of 20 and 39.

I finished my cancer treatment aimed at curing it within the last three years.

Smartphone access

Exclusion Criteria

Significant psychological disabilities

I finished my cancer treatment over three years ago or am currently in treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week phone- and app-based intervention to promote hope and mitigate life disruption caused by cancer diagnosis and treatment

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of hope, quality of life, and health behaviors

6 months

Treatment Details

Interventions

• Empirically Supported Protocol
• Health Education

Trial Overview The trial is testing an 8-week phone and app-based intervention designed to boost hope and improve quality of life after cancer treatment. It involves comparing this new method with a control group in a randomized controlled trial among 150 young adult survivors.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The intervention utilizes an empirically supported protocol, further refined with evidence-based strategies targeting the needs of young adult (YA) survivors. Its long-term goal is to promote hopeful thinking, and ultimately enhance other long-term markers of quality of life (QOL) (including mental health and health behaviors). The intervention follows 8 weekly curricula, reinforced through psychoeducation and skill-building, homework/practical application, and self-monitoring. Its 8-week design was informed by cognitive behavioral therapy and positive psychology intervention literature.

Group II: Attention Control Active Control 1 Intervention

Health education regarding maintaining a healthy weight, physical activity, and nutrition, based on American Cancer Society and NCI guidelines/recommendations.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+